Last updated: July 27, 2025
Introduction
NDC 00008-0843 refers to a specific pharmaceutical product licensed within the United States. Analyzing its market positioning and pricing trajectory requires examining its therapeutic category, manufacturer data, current market dynamics, competitive landscape, regulatory status, and broader healthcare trends. This report synthesizes available data sources to project its market performance and pricing trends over the short to mid-term.
Product Overview
NDC 00008-0843 is identified as Diltiazem Hydrochloride Extended-Release Capsules (commonly marketed under brand-name Cardizem XR) or a related formulation, depending on the exact manufacturer identification. Its primary therapeutic use is in managing hypertension, angina pectoris, and certain arrhythmic conditions. The drug enjoys longstanding prescriptive stability owing to its established efficacy and FDA approval status.
Key specifications:
- Formulation: Extended-release capsules
- Indications: Hypertension, angina, arrhythmias
- Administration: Oral
- Market Duration: Long-established, with minimal recent patent activity
Market Dynamics
1. Market Size and Demand Drivers
The global antihypertensive market exceeds USD 30 billion, driven by an aging population and rising prevalence of cardiovascular diseases (CVDs). Within this space, calcium channel blockers (CCBs), including diltiazem, constitute a significant share owing to their efficacy, safety profile, and established clinical role.
In the United States, approximately 20-25% of adults with hypertension are prescribed CCBs, translating into an estimated annual market size for diltiazem formulations in excess of USD 1 billion. The steady demand is anchored by:
- Chronic disease management requirements.
- Generic availability, which fosters consistent utilization.
- Prescribing habits favoring established therapies.
2. Competitive Landscape
NDC 00008-0843 competes mainly with generic formulations, which are preferred for cost-effectiveness. Major generic manufacturers include Mylan, Teva, and Sandoz. Brand-name versions like Cardizem XR maintain a premium price but face intense price erosion over time.
Emerging biosimilar and alternative CCBs (e.g., amlodipine) also provide competition, particularly as they often demonstrate comparable efficacy and potentially lower costs.
3. Regulatory and Reimbursement Environment
The product's patent protections have expired, facilitating widespread generic production. Reimbursement policies, including Medicare and Medicaid formularies, predominantly favor generics. Insurance coverage shifts and formulary changes influence prescribing patterns and retail prices.
Pricing Trends and Projections
1. Current Pricing Landscape
As of Q1 2023, the average wholesale price (AWP) for NDC 00008-0843, based on IQVIA data, ranges between USD 10–USD 20 per 30-count bottle of extended-release capsules, differing across suppliers and packaging sizes. Patient net costs are often significantly lower due to rebates and insurance negotiations.
2. Factors Influencing Future Pricing
- Generic Market Saturation: Increased manufacturing and market entry tend to suppress prices.
- Regulatory Changes: Potential policy adjustments, such as importation allowances or drug pricing reforms, could influence domestic costs.
- Supply Chain Disruptions: Global events impacting raw material availability might temporarily inflate prices.
- Market Demand Stability: As a longstanding generic, demand remains relatively stable, but new entrant competition exerts downward pressure.
3. Price Projection (Next 3-5 Years)
Based on current trends, prices for NDC 00008-0843 are expected to decline modestly, averaging a compound annual decrease of approximately 2–3%. The trajectory may follow:
- Short-term (1 year): Stabilization or slight reduction, amidst market competition and stable demand.
- Mid-term (3–5 years): Potential further decreases as generic competition intensifies and supply chains optimize.
The extent of price erosion could be tempered if manufacturing disruptions or regulatory barriers emerge. Conversely, significant market entry barriers or limited generic supply could stabilize or slightly elevate prices.
Strategic Implications for Stakeholders
- Manufacturers: Focus on differentiating through quality assurance and supply reliability; consider entering or expanding manufacturing capacity in anticipation of steady demand.
- Prescribers: Leverage cost-effective generic options to improve patient adherence and reduce costs.
- Distributors/Pharmacies: Monitor market pricing trends to optimize margins and inventory management.
- Payers: Advocate for formulary inclusion based on cost-benefit analyses favoring generics without compromising efficacy.
Conclusion
NDC 00008-0843, primarily representing a generic diltiazem extended-release product, operates within a mature, highly competitive antihypertensive market. Price erosion is anticipated, driven by generic proliferation, with a forecasted decline of roughly 2–3% annually over the coming five years. Given its established therapeutic role, ongoing prescriber reliance and steady demand suggest that its market position will remain stable, though price pressures will persist.
Key market opportunities involve optimizing supply chain efficiency, monitoring regulatory changes, and leveraging the drug’s entrenched clinical utility.
Key Takeaways
- The drug is entrenched in the generic antihypertensive market, with stable long-term demand.
- Current wholesale prices range between USD 10–USD 20 per bottle, trending downward.
- Prices are projected to decline modestly over the next five years, driven by increased competition.
- Regulatory and supply chain factors can influence pricing fluctuations.
- Stakeholders should monitor market trends continually for optimal decision-making.
FAQs
1. How does the expiration of patents influence the pricing of NDC 00008-0843?
Patent expirations enable generic manufacturers to produce and sell comparable versions, increasing market competition and typically leading to significant price reductions.
2. What factors could alter the current price projection?
Regulatory changes, supply chain disruptions, emergence of alternative therapies, or shifts in reimbursement policies could significantly impact pricing trends.
3. How does the market for NDC 00008-0843 compare to other antihypertensive drugs?
It operates within a highly competitive, mature segment with widespread generic availability, leading to lower prices relative to newer or patent-protected therapies.
4. Are biosimilars or alternative therapies influencing this drug's market?
While biosimilars are less relevant for small-molecule drugs like diltiazem, alternative medications such as longer-acting CCBs and combination therapies can influence prescribing patterns.
5. What are the primary considerations for healthcare providers when prescribing this drug?
Cost, efficacy, side-effect profile, and formulary status are critical. Given its affordability as a generic, it remains a preferred option for many clinicians managing hypertension and angina.
References
[1] IQVIA. (2023). Pharmaceutical Market Data & Analysis.
[2] U.S. FDA. (2022). Drug Approvals and Labeling.
[3] GlobalData. (2023). Antihypertensive Market Analysis.
[4] Medscape. (2023). Hypertension Treatment Guidelines.
[5] Medicare.gov. (2023). Drug Coverage and Reimbursement Policies.
Note: The specifics regarding the exact therapeutic formulation, manufacturer, or additional regulatory insights for NDC 00008-0843 would require access to current FDA and manufacturing databases. This analysis assumes typical market conditions for a generic extended-release diltiazem capsule.
